Zafgen’s beloranib obesity drug meets primary efficacy endpoint in phase 2b trial

During the trial, patients given 1.8 mg and 1.2 mg doses of the beloranib drug experienced 12.7% and 13.5% reduction in body weight, respectively. Patients given a placebo just lost 3.1% of their weight.

The company said patients enrolled in both the 1.8 mg and 1.2 mg treatment arms also met a key secondary endpoint, with subjects in each dose arm achieving on average an absolute reduction in HbA1c of 2% compared to a reduction of 0.6% for placebo.

Last month, Zafgen said the drug was also successful in treating Prader-Willi syndrome in a late-stage trial.

It demonstrated significant and clinically meaningful weight loss and improvement in hyperphagia-related behaviors.

Zafgen CEO Thomas Hughes said: "In addition to the recent positive efficacy data from our bestPWS clinical trial, these data provide additional context regarding beloranib’s benefit-risk profile in the treatment of severe forms of obesity.

"We look forward to discussing these results with the FDA as we work to establish a path forward for beloranib in Prader-Willi syndrome and other orphan obesity indications."

Beloranib inhibits MetAP2, an enzyme that changes the activity of key cellular processes that control metabolism.

Zafgen said if a person becomes obese, the body undergoes several metabolic changes and becomes programmed to create and store more fat, making it much more difficult to reduce body weight.

Beloranib is thought to help reduce hunger and restore balance to fat metabolism, allowing calories to once again be used as a productive energy source.

Zafgen licensed beloranib from Chong Kun Dang Pharmaceutical Corporation of South Korea.

Image: Beloranib inhibits MetAP2, an enzyme that changes the activity of key cellular processes that control metabolism. Photo: courtesy of zole4/FreeDigitalPhotos.net.